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Recruiting

NCT Number: NCT06691932

At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)

The purpose of this study is to define human milk (HM) as an ecosystem which investigators will then combine into temporal models of milk dynamics to accurately describe HM chronobiology. This study addresses 4 crucial public health gaps: 1) how breast milk changes over time and over the day, 2) how milk dynamics are related to infant sleep patterns, 3) how milk dynamics are related to infant microbiome dynamics, and 4) how all these relationships differ between infants fed directly at-the-breast vs pumped milk. These fundamental insights have been unknown until now, so that families who feed pumped breast milk are completely underserved. These results are critical to optimizing infant feeding and health outcomes for all infants receiving breast milk.

Recruiting

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Key information

Conditions

Breast Feeding Behavior Exclusive Breastfeeding Feeding Behavior

Age range

0 day–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location status: Recruiting

Location contact

Kaili Widrick, MS

CONTACT

[email protected]

5852758991

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lactating mothers between 20-40 years old at enrollment

o 120 mother/infant dyads who primarily feed HM ATB (average >75% of feeds,

  • pumping no more than one time per day)

o 120 mother/infant dyads who predominantly feed expressed HM (average >75% of feeds)

  • All races and ethnicities may enroll
  • Singleton infant delivered after 37 weeks
  • Infant between the ages of 0-1 months at the time of enrollment.
  • No serious health complications in mother or infant

Exclusion criteria

  • Non-English-speaking subjects as study personnel only speak English
  • Lactating moms who will be feeding both ATB and expressed HM (over 25% of the time in either feeding mode)
  • Infant supplementation with formula ≥10 oz before sample collections begin, and/or no more than 16 oz during active participation/ sample collections.

Treatment and study plan

Primary outcomes

  1. Infant Sleep Latency

    Time frame: Baseline, 2 months and 4 months

    The time to fall asleep after bedtime(minutes)

Study contacts

Contact information is provided by the study sponsor or research team.

Kaili Widrick, MS

CONTACT

[email protected]

5852758991

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: BEGIN

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 18, 2024
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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